Abstracts by keywords: Early Benefit Assessment
“Interim assessment of the experiences so far with AMNOG”
The Medicines Market Reorganization Act (AMNOG) has been in force since January 1, 2011. The introduction of this legal system represents a paradigm shift, comparable to the fixed price regulation introduced in 1989. The background to the AMNOG was the legislature's desire to counteract the “cost explosion” in the health system while at the same time ensuring an adequate supply of medicines. The implementation of the AMNOG regulations primarily means the implementation of the early benefit assessment in accordance with Section 35a SGB V. This system is based in particular on comparable models from the Scottish Medicine Consortium (SMC) and the English National Institute for Clinical Research (NICE).